The Flowtron ACS800 pump is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs.
It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments.
The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly.
Each garment is compressed alternately, applying pressure to the patient's limb. to help prevent deep vein thrombosis.

AI/ML Overview

This device, the Flowtron ACS800 Pump and Tri Pulse Garments, is a pneumatic pump system designed to help prevent Deep Vein Thrombosis (DVT). Its clearance is based on demonstrating substantial equivalence to predicate devices: the Flowtron Universal AC600 (K010744) for the pump and the STS garments (K012008) for the Tri Pulse garments.

The provided document describes various tests performed to demonstrate this equivalence, primarily focusing on bench testing of the device's functionality and performance rather than clinical studies with human subjects.

Here's an analysis of the available information against your requested points:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to predicate devices through various tests. The reported performance refers to the satisfactory outcomes of these tests.

Acceptance Criteria/Test Description	Reported Device Performance
Full validation of pump software / hardware functionality (Garment detection, Therapy delivery)	Passed
Performance testing garments - Pressure cyclic test (with Tri Pulse, Foot, and DVT garments)	Passed
Real Time - life testing - pump	Confirms specification (implies meeting predefined durability/lifetime requirements)
Vibration testing - pump	Passed
Electrical Testing to Standard IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)	Complies with Standard
EMC testing to Standard EN 60601-1-2, 2007	Complies with Standard
Tri Pulse garment biocompatibility testing to standards ISO10993-1, ISO10993-5 & ISO10993-10	Complies with Standards
Compression pressure / time profiles for DVT and Foot Garments (for Flowtron ACS800 pump equivalence)	Stated as having "the same compression pressure / time profiles" as the predicate Flowtron Universal AC600 (K010744).
Sequential compression profiles for Tri Pulse garments (for equivalence to STS garments)	Stated as having "similar sequential compression profiles" to the predicate STS garments (K012008) using three-chamber garments.

Study Details:

Based on the provided document, the regulatory submission relies heavily on bench testing and comparison to predicates rather than a primary clinical study with a test set of patient data.

Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of human subjects or patient data. The "test set" here refers to physical prototypes of the device components (pump, Tri Pulse garments, DVT garments, Foot garments) undergoing various engineering and performance tests.
- Data provenance: Not applicable. The data is generated from laboratory bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for bench testing is defined by engineering specifications, international standards (e.g., IEC, EN, ISO), and performance of predicate devices. This type of evaluation does not typically involve human expert consensus for "ground truth" as it would for image interpretation or diagnosis.
Adjudication method for the test set: Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies with human evaluations (e.g., blinded reading of medical images). For bench testing, results are typically determined by instrument readings against predefined pass/fail criteria or direct comparison to predicate device performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical pump and garment system, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself "stands alone" in its automated function (pump delivering compression to garments). The tests described (functionality, performance, life testing) assess this standalone performance against specified criteria and predicate devices. There is no "algorithm only" component in the sense of a software-based diagnostic or AI tool being evaluated separately from a human operator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established through:
- Engineering specifications: Predefined performance parameters (e.g., pressure, timing, durability).
- International standards: Compliance with recognized safety and performance standards (IEC 60601-1, EN 60601-1-2, ISO 10993 series).
- Predicate device performance: Directly comparing the new device's performance to that of previously cleared devices to establish equivalence in function and safety.
The sample size for the training set: Not applicable. This submission does not involve machine learning or AI models that require training sets.
How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Summary

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ARJOHUNTLEIGH

getinge group

FEB 2 8 2014

1433119

510(K) Summary

Flowtron ACS800 Pump and Tri Pulse Garments

Name & Address:	ArjoHuntleigh Polska Sp z.o.o.Ul. Ks Wawrsyniaka 262052 KomornikiPoland
Telephone:	+(44) 2920 485885
Fax:	+(44) 2920 492520
Prepared:	2 January 2014
Contact:	David Moynham – Regulatory Affairs Engineer
Device Name:	Flowtron ACS800 Pump and Tri Pulse Garments
Common Name	Compressible Limb Sleeve
Classification	Class	Product Code	Classification Regulation
	II	JOW	870.5800
Classification Name:	Sleeve, Limb, Compressible
Predicate Devices:	Flowtron Universal AC600 (K010744) cleared 26 Mar 2002, originallymanufactured by Huntleigh Healthcare Ltd.andSTS garments (K012008) cleared 21 Sept 2001 originally manufacturedby Huntleigh Healthcare Ltd.Huntleigh Healthcare was acquired by the ArjoHuntleigh AB group andall rights to properties and registrations assigned to HuntleighHealthcare are now wholly owned by ArjoHuntleigh AB.
Indications for Use:	To help prevent Deep Vein Thrombosis (DVT)
Description :	The Flowtron ACS800 pump is a pneumatic pump that suppliescompressed air to inflate compression garments that are attached topatient's limbs.It is designed to work with the ArjoHuntleigh ranges of DVT calf/thighcompression garments, Foot compression garments and Tri Pulsecalf/thigh compression garments.The pump automatically senses the type of compression garmentconnected and adjusts the pressure/time cycle accordingly.Each garment is compressed alternately, applying pressure to thepatient's limb. to help prevent deep vein thrombosis.

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ARIOHUNTLEIGH GETINGE GROUP

Models:

Model REF	Device	Features
513003	Flowtron ACS800	AC powered pump
513003OR	Flowtron ACS800	AC powered pump with longer length connectiontubes
TRP10, TRP20,TRP30, TRP40 &TRP60	Tri Pulse garments.	Sequential inflation providing active compression.

Substantial Equivalence:

Flowtron ACS800 pump is substantially equivalent to cleared device Flowtron Universal AC600 (K010744). The Flowtron ACS800 pump has the same compression pressure / time profiles for the DVT and Foot Garments.

The equivalence of the Tri Pulse garments is demonstrated using bench testing against the predicate STS garments (K012008).

Tri Pulse garments are substantially equivalent to cleared device STS garments (K012008) having similar sequential compression profiles using three-chamber garments.

Both devices are intended to be used together as a system.

Testing to demonstrate equivalence included

Testing conducted	Result
Full validation of pump software / hardware functionality, including- Garment detection- Therapy delivery	Passed
Performance testing garments - Pressure cyclic test.with Tri Pulse garmentswith Foot garmentswith DVT garments	Passed
Real Time - life testing - pump.	Confirmsspecification
Vibration testing - pump.	Passed
Electrical Testing to Standard IEC 60601-1: 2005.+ CORR. 1 (2006) + CORR. 2 (2007)	Complies withStandard

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ARJOHUNTLEI GETINGE GROUP

EMC testing to Standard EN 60601-1-2, 2007	Complies withStandard
Tri Pulse garment biocompatibility testing tostandardsISO10993-1, ISO10993-5 & ISO10993-10	Complies withStandards

Technologies Summary: The Flowtron ACS800 pump contains an air compressor, air distribution valve and a microprocessor based control system, housed in a durable plastic casing.

The control system sets and monitors the air pressure cycle applied to the compression garments. It also monitors for faults caused by incorrect user set-up, compression garment failures and pump system problems.

Automatic compression garment recognition is achieved by sensing a The value inductor is built into the specific value inductor. compression garment hose connector.

Tri Pulse garments are constructed with a three-chamber bladder enclosed in a polyester garment, which is wrapped around the limb and secured with hook and eye tabs. When connected to the pump, the garment inflates through a single connecting tube to generate a sequential compression effect on the limb.

Conclusion:

The data detailed within submission including that drawn from the nonclinical tests demonstrate that the device is as safe and effective as the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Image /page/3/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three overlapping wings, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

February 28, 2014

Arjohuntleigh Polska Sp z.o.o. Mr. David Moynham Senior Regulatory Affairs Engineer ArioHuntleigh AB 35 Portmanmoor Road Cardiff, CF24 5HN UK

K133119 Re:

Trade/Device Name: Flowtron ACS800 pump and Tri Pulse garments Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 22, 2014 Received: January 27, 2014

Dear Mr. Moynham:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Mr. David Moynham

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M FDA

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ARJOHUNTLEIGH GETINGE GROUP

K133119 510(k) Number:

Device Name: Flowtron ACS800 and Tri Pulse garments.

Indications for Use:

To help prevent Deep Vein Thrombosis (DVT)

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Williams

Premarket Notification (510(k))

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).